Infant/Pediatric Resting ECG Electrodes for 12-lead


Product Overview

Infant/Pediatric Resting ECG Electrodes for 12
BabyMAC - 402207-810


Device Description

A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep Dry
  • Special Storage Condition, Specify
    • Keep Away from Sunlight
  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 41.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DRX

    Device Name: Electrode, Electrocardiograph

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.2360

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 20885403252218

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 70885403252213

    Package Quantity: 10

    Package Discontinue Date: 3/31/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Box


    Device Id: 70885403252213

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 10885403252211

    Device Type: Unit of Use

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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